1. Field of the Invention
The present invention relates to an apparatus for compounding medicinal and/or nutritional liquids from a plurality of pharmaceutical supply bottles to provide a single mixed liquid, and also to a disposable supply set and receiving set for use with such a compounder apparatus.
2. Discussion Of the Prior Art
Numerous illnesses and treatment side effects inhibit normal functioning of the human digestive track, presenting a need for a parenteral supply of nutrition to the patient which bypasses the ailing digestive track.
It is conventional for a hospital or home pharmacy to have on hand a supply of various nutritional fluids which may be compounded in accordance with any desired formula to furnish a particular patient with the nutritional requirements specific to that patient. Such compounders typically include one or more pumps and a support means overhanging the pumps for supporting a plurality of supply bottles on the device. Each of the supply bottles holds a different nutritional fluid, or medicinal fluid if desired, and the pumps draw fluids from the bottles successively, and mix or compound the fluids into a single receiving container that is then ready for use with the patient.
By combining the various available fluids together, it is possible to provide total parenteral nutrition (TPN) to the patient. For example, fluids including dextrose (sugar), fatty acids (fats), amino acids (protein), electrolytes (sodium, potassium etc.), or other nutritional fluids may be compounded with sterile water to provide any particular patient with all of their nutritional requirements without the need for enteral introduction of such nutrients.
In order to reduce the opportunity for germs and bacteria to contaminate the fluid being mixed in a conventional apparatus, it is known to provide both a disposable supply set and a disposable receiving set for use with the compounder. The supply set includes a plurality of lines, each including a pair of relatively clear, small diameter tubing sections formed of polyvinylchloride (PVC) and an intermediate, large diameter tubing section formed of silicon tubing coupled between the two PVC sections. The supply set also includes a manifold having a plurality of inlets to which the lines are attached, and a single outlet through which liquid is dispensed. A valve is positioned within the outlet of the manifold in an attempt to prevent liquid from leaking from the manifold.
The receiving set includes a receiving bag, a line connected to the bag, and an end connector for connecting the line to the outlet of the manifold. The end connector presents a tubular male member which penetrates the outlet of the manifold during setup and opens the valve to allow liquid to flow to the bag.
Numerous problems are presented by conventional compounders and the sets used to transfer fluid from the various supply bottles to the receiving bag. For example, because as many as five or more supply bottles are supported on the apparatus for any given mixing operation, tubing from the lines of a conventional supply set easily become tangled, or are inadvertently connected to the wrong bottles by an operator during setup so that the formula mixed is incorrect. Further, it is possible for a line to be improperly threaded through the associated pump of the device so that the pump is unable to pump liquid through the line, or so that the line is out of registration with any convetional type of flow sensor mounted alongside the pump.
Another problem present in conventional compounder constructions relates to the absence of any reliable means in the manifold of the supply set to prevent fluid within the manifold from being reintroduced into the various supply lines from the manifold when fluid is not being pumped through those lines. As a result, it is possible that fluid from one supply bottle does not reach the receiving bag, but rather is pumped through the manifold back into one of the remaining lines of the supply set. Such displacement of the fluid reduces the accuracy of the apparatus and adversely affects the quality of the mixture produced.
Further although it is known to provide a valve in the outlet of the manifold, conventional valves represent a weak effort to actually prevent leakage, resulting in constructions which provide less than desirable results. Such leakage is significant where the apparatus is to be used to measure a very accurate dosage of nutritional or medicinal liquid from a bottle to the receiving bag, and renders the conventional construction impractical.